Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinCompleted

Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression: a pilot study (PSILODEP-PILOT)

This open-label trial (n=12), also known as PSILODEP-PILOT is the first to test psilocybin in patients in the UK. The study found psilocybin (10-25mg, x2) to be well-tolerated.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, interventional Phase II pilot in treatment-resistant major depression testing two single oral doses of psilocybin (10 mg and 25 mg) given one week apart in the same participants.

Primary outcome: QIDS measured at baseline, one day and one week post-dose; secondary outcomes include BDI, HAM-D and MADRS. Safety and tolerability were reported and multiple peer-reviewed results publications are linked to the registry record.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Open-label treatment with two oral psilocybin doses separated by one week (within-subject).

Interventions

  • Psilocybin10 - 25 mg
    via Oral• two sessions• 2 doses total

    Two oral doses: 10 mg and 25 mg, separated by one week.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D)
  • 2. No improvement despite two courses of antidepressant treatment for adequate duration (≥6 weeks) within current episode
  • 3. No magnetic resonance imaging (MRI) contraindications

Exclusion Criteria

  • 1. Current or previously diagnosed psychotic disorder
  • 2. Immediate family member with a diagnosed psychotic disorder
  • 3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc)
  • 4. History of suicide attempts
  • 5. History of mania
  • 6. Blood or needle phobia
  • 7. Positive pregnancy test at screening or during the study
  • 8. Current drug or alcohol dependence
  • 9. Allergy to gelatine or lactose
  • 10. Lack of appropriate use of contraception
  • 11. Breastfeeding

Study Details

Locations

Imperial Clinical Research Facility — London, United Kingdom

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